DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 3-5 are objected to because of the following informalities:
Claim 3, line 1 “plurality of candidate PWVs” should be “plurality of candidate PWV metrics”.
Claim 4, line 3 “the determine PWV metric” should be “the determined PWV metric”.
Claim 5, line 5 “the determine PWV metric” should be “the determined PWV metric”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites “the position” and “the first local maximum”. There is insufficient antecedent basis for these limitations of the claim. Furthermore, it is unclear if the claim is intended to depend from claim 1 as written or if it should depend from claim 10, which introduces each of these elements.
Claim 13 recites “the curved feature”, “the transition”, “the systolic phase”, “the diastolic phase”, and “the cardiac cycle”. There is insufficient antecedent basis for these limitations of the claim. Furthermore, it is unclear if the claim is intended to depend from claim 1 as written or if it should depend from claim 10, which introduces each of these elements.
Claim 14 recites “the downward slope” and “the first local maximum”. There is insufficient antecedent basis for these limitations of the claim. Furthermore, it is unclear if the claim is intended to depend from claim 1 as written or if it should depend from claim 10, which introduces each of these elements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "comparing the one or more morphological features with one or more features from a plurality of baseline PPG signal morphologies associated with a plurality of chronological ages based at least in part on extracting the one or more morphological features; determining a cardiovascular health metric that indicates a cardiovascular health of the user based at least in part on the comparison; determining a pulse wave velocity (PWV) metric that indicates an arterial stiffness of the user based at least in part on the cardiovascular health metric". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim 1 satisfies Step 1, namely the claim is directed to one of the four statutory classes, process. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claim 1, the limitations " comparing the one or more morphological features with one or more features from a plurality of baseline PPG signal morphologies associated with a plurality of chronological ages based at least in part on extracting the one or more morphological features; determining a cardiovascular health metric that indicates a cardiovascular health of the user based at least in part on the comparison; determining a pulse wave velocity (PWV) metric that indicates an arterial stiffness of the user based at least in part on the cardiovascular health metric" are abstract ideas as they are directed to a mental process, as comparisons and determinations may be made in the human mind based on received data, such as by observing an extracted morphological feature and comparing that extracted feature with a features in a database to determine a most similar database entry. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements “receiving a photoplethysmogram (PPG) signal representative of a pulse waveform for a user from a wearable device; extracting one or more morphological features associated with the PPG signal” and “causing a graphical user interface to display an indication of the cardiovascular health metric, the PWV metric, or both”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step and output a result of the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The receiving and extracting steps lead to the final limitation of “determin[ing]” and “display[ing]” such that the end result of use of the system is only an output of a determined indication which may be any generic output. As this determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case the measurement of data relating to first and second physiological information, such that the claim does not integrate the judicial exception into any practical application. Furthermore, while the abstract idea itself may be an improvement over the existing technology, per Genetic Technologies Limited v. Merial LLC (Fed Cir., 2016) the inventive concept of step 2 of the Alice/Mayo analysis cannot be supplied by the abstract idea. The inventive concept necessary at step two of the Mayo/Alice analysis cannot be furnished by the unpatentable abstract idea itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered abstract idea cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. For this reason, the abstract limitations may not be seen as an improvement which integrates the judicial exception into a practical application. Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed step of the process may be performed by a person in an undefined manner) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The limitation of “receiving a photoplethysmogram (PPG) signal representative of a pulse waveform for a user from a wearable device; extracting one or more morphological features associated with the PPG signal” and “causing a graphical user interface to display an indication of the cardiovascular health metric, the PWV metric, or both” constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic display and PPG sensor, which Rundo (US 20220273183 A1) describes as well-understood, routine, or conventional in its description of a conventional display unit in an acquisition instrumentation circuit including a screen or printer (Paragraph 0103) and known, standard manners of acquiring PPG waveforms (Paragraph 0123) using conventional PPG sensors (Paragraph 0143). Pantelopoulos (US 10973422 B2) and Lizio (US 20210030372 A1) similarly disclose a PPG sensing device including a display as well-understood, routine, or conventional. As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claim 1 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 19-20 are rejected for similar reasons.
Regarding “one or more processors” or “a processor” performing the limitations of claims 19 and 20, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the processor(s) are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes.
Claims 2-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 1, which was rejected under 35 U.S.C. 101 in paragraph 10 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 1, or comprise significantly more than the limitations of claim 1.
Besides the abstract idea of claim 1, claims 2-6, 8-9, 15-17 recite additional elements of the abstract idea which are themselves abstract, as steps of “identifying”, “matching”, “adjusting”, “generating one or more recommendations”, “determining”, “computing a deviation” may all be performed in the human mind. Claims 3-7, 17-18 additionally recite further details of mere data output as they are directed toward details of the display on a graphical user interface which are extra-solution activity and thus do not integrate the judicial exception into a practical application. Claim 10-14, 17 recites further details of mere data gathering to provide data for the mental process step as they are directed to additional details of the extracting of morphological features and toward the acquisition of additional data as input to adjust a mental process determination which thus serves as extra-solution activity and thus do not integrate the judicial exception into a practical application.
The claim element of claim 1 of a method is recited with a high level of generality (as written, the actions of the processing circuitry may be carried out by a person alone or with a generic computer in any undefined manner). This limitation provides no practical application, nor does it provide meaningful limitations to the abstract idea.
Conclusion
Claims 1-20 are not currently rejected under 35 U.S.C. 102/103.
The prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, “comparing the one or more morphological features with one or more features from a plurality of baseline PPG signal morphologies associated with a plurality of chronological ages based at least in part on extracting the one or more morphological features; determining a cardiovascular health metric that indicates a cardiovascular health of the user based at least in part on the comparison; determining a pulse wave velocity (PWV) metric that indicates an arterial stiffness of the user based at least in part on the cardiovascular health metric”.
The most pertinent prior art, Lizio (US 20210030372 A1), discloses a method comprising: receiving a photoplethysmogram (PPG) signal representative of a pulse waveform for a user (Paragraph 0104, 0252—measure two PPG signals…; Fig. 1.4) from a wearable device (Paragraph 0103, 0249-0251—the subject wearing the PPG sensors…a wrist-worn device, such as a fitness tracker or a smartwatch);
extracting one or more morphological features associated with the PPG signal (Paragraph 0036-0043, 0074-0078, 0254-0256--processor 102 (for example, a hardware unit, an apparatus, a Central Processing Unit (CPU), a Graphics Processing Unit (GPU)) can be configured to receive and process the periodic light received from the PPG sensors 101. The processing includes pre-processing of the data at first instance as discussed before and estimation of the cardiovascular parameters with help of the algorithms according to the present invention… the electronic device 100 extracts a plurality of parameters from both PPG signals, after preprocessing of the signal, including the PPG features, the HRV features, the APG features and the pulse transit time (PTT). Based on the two PPG signal analysis, the cardiovascular parameters can be estimated as described above; Fig. 1.6, characteristic points a-e are required to estimate the vascular age index);
comparing the one or more morphological features with one or more features from a plurality of baseline PPG signal morphologies associated with a plurality of chronological ages based at least in part on extracting the one or more morphological features (Paragraph 0044, 0251-0256--database 103 contains reference data for all cardiovascular parameters and may be derived from physiological data obtained from different organizations databases and obtained from measured data of the system 100…The estimated cardiovascular parameters are then compared with prestored data 104);
determining a cardiovascular health metric that indicates a cardiovascular health of the user based at least in part on the comparison (Paragraph 0014, 0076-0080, 0140—Vascular age index AgIx…this index was also estimated…To more reliable estimate AgIx, a new linear regression model…was developed…); and
causing a graphical user interface to display an indication of the cardiovascular health metric, the PWV metric, or both (Paragraph 0131, 0256-0257).
Lizio additionally discloses determining a pulse wave velocity (PWV) metric (Paragraph 0081-0088, 0221-0224, 0230-0231). However, Lizio discloses determining a PWV metric through direct measurement or through a linear regression using pulse transit time values, age, height, median heart rate value, and parameters of the PPG signal such as crest time, stiffness index, and pulse area. Lizio provides no disclosure or motivation for utilizing the cardiovascular health metric (in this case, a vascular age index) as an input for determining a pulse wave velocity metric.
Park (US 20130324859 A1) additionally discloses comparing the one or more morphological features with one or more features from a plurality of baseline PPG signal morphologies associated with a plurality of chronological ages based at least in part on extracting the one or more morphological features and determining a cardiovascular health metric that indicates a cardiovascular health of the user based at least in part on the comparison but lacks any disclosure or suggestion of determining a pulse wave velocity (PWV) metric that indicates an arterial stiffness of the user based at least in part on the cardiovascular health metric. In fact, Park instead uses a PWV value to extract features such as a vascular aging index rather than using such an index to determine a PWV value.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
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/ANNA ROBERTS/Examiner, Art Unit 3791
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